A clinical trial to compare three different regimes for treatment of nutritional rickets in childre
Phase 2
Completed
- Conditions
- Health Condition 1: E550- Rickets, active
- Registration Number
- CTRI/2018/04/013300
- Lead Sponsor
- Maulana Azad Medical College and Lok Nayak Hospital and GIPMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Diagnosis of nutritional rickets defined by clinical, biochemical and radiological parameters.
2. Residence within 50 km of hospital who are willing for follow up visits
Exclusion Criteria
1. Patients with confirmed or suspected diagnosis of malabsorption or chronic kidney or hepatic disease.
2. Patients with severe systemic illness compromising oral intake (tachycardia, tachypnea, shock, weak peripheral pulses, increased capillary refill time).
3. Patients who have taken calcium supplements or vitamin D preparation in last 6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of children who will achieve complete radiological healing (defined as radiological score â?¤ 1.5) at 12 weeks across three regimes <br/ ><br> <br/ ><br>Timepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method 1)Increase in serum 25(OH) D3 at 12 weeks <br/ ><br>2)Decline in PTH level at 12 weeks <br/ ><br>3)Decline in ALP level at 12 weeks. <br/ ><br>4)Proportion of children with severe vitamin D deficiency (serum 25OHD less than 12ng/mL) <br/ ><br>Timepoint: 12 weeks